Fixation device for the fixation of bone fragments

ABSTRACT

A fixation device for the fixation of bone fragments, applicable to the mutual fastening of bone fragments temporarily separated during a surgical operation or as a result of a trauma. The device is also suitable for the fixation of a bone flap in the replacement thereof in a corresponding aperture made in the cranium or cranial bone mass. The device is made of biocompatible material and comprises a flexible strip and fastening means, the strip having a length allowing the formation of a fastening loop tightly fastening the bone fragments to be joined together. The fastening means are provided with at least one opening provided with interlocking means allowing the passage of a free end of the strip and preventing its extraction in the direction opposite to the insertion.

TECHNICAL FIELD OF THE INVENTION

The invention relates to a fixation device for the fixation of bonefragments, applicable to the mutual fastening of bone fragmentstemporarily separated during a surgical operation or as a result oftrauma. The device according to the invention is also suitable for thefixation of a bone flap in the replacement thereof in a correspondingaperture made in the cranium or cranial bone mass.

BACKGROUND OF THE INVENTION

When under certain circumstances bone tissue is fractured or broken, itmust be welded together again in order to recover its initial state. Tothat end there are many different devices which are used in the event ofbreaking due to trauma or accident, or in the event that bone tissuemust be previously broken or fractured in the operating room in order toperform surgery.

The devices used to join bone fragments generally consist of clamps, theparallel ends of which are inserted into each of the bone fragments tobe joined together. An example of this type of device is the onedescribed in patent EP 1171050 B1, in which the two fragments of thesternum that must be joined together after a surgical operation on thechest (cardiovascular, pulmonary . . . ) are fixed by the action of aC-shaped clamp with a center piece from which ends opposite to oneanother originate, said clamp provided with a loop in the area of thecenter piece which is deformed when cooled to be able to apply the endsto the bone fragments of the sternum and which, once applied on the bonemass, returns to its original shape when it reaches body temperature,comprising the mentioned ends and therefore the joining of thefragments.

Other clamp-shaped devices are described, each having its ownparticularities, in patent documents U.S. Pat. No. 5,449,359, U.S. Pat.No. 5,788,698, U.S. Pat. No. 4,456,006 and U.S. Pat. No. 484,328.

Alternatively, surgical connectors can also be used to join bonefragments such as the connector described in U.S. Pat. No. 5,743,913 A1,in which a slightly curved plate provided with multiple openings andnodes homogenously distributed therethrough comprises at least threealso slightly curved extensions or ribs joined to at least three ofthese nodes and suitable for receiving fastening means, such as screws.

All these devices involve the drawback that they are difficult to apply,requiring the use of applicator devices and/or additional instrumentsthat are also very complex, or requiring additional elements forsecuring them in the bone fragments that must be joined together.

In the same manner, devices are widely used in the field ofneurosurgical operations for the fixation of flaps or bone fragmentswhich are generally provided with means for the fastening of the flaps,and suitable for being supported on or containing the cranial bone massin a space reserved for such purpose, or by incision by means of a sharpelement in said cranial mass. These devices are placed between the flapand the cranial bone, and except in the event that they are made of abiodegradable or absorbable material, they are permanently placed in thecranium.

One of the existing and widely used types of flap fixation devicesgenerically consists of a device with two considerably circular elementsfacing one another in the form of semi-spherical caps joined by means ofa shaft or shank through which the semi-spherical elements can be movedcloser to one another in order to adjust the device to the cranium andflap bone mass thickness. Once the mentioned device is adjusted, boththe flap and the cranial bone mass are supported between thesemi-spherical elements, forming the bearing and supporting means of theflap and of the cranium. In this type of device, the neurosurgeon cutsthe excess remaining shank once it is well placed between bone masses.

Patent document EP 1477122 A2 describes a device such as those describedin the preceding paragraph consisting of an implant for adjacent cranialbone fragment fixation, comprising two fastening elements, an endelement and an inner element, which by means of a joining element, whichis wire, that is adjustable and can be led through the externalfastening element, causes the sliding of the inner fastening element,which comes close to the external fastening element, said wire being ledthrough multiple openings made in the fastening elements. The devicedescribed in EP1477122 A2 comprises additional joining means between theinternal and external fastening elements, such as shafts perpendicularto the mentioned internal and external fastening elements, which canconsist of ratchet teeth systems, clips or fragments with a trapezium-or triangular-shaped longitudinal section with side-projecting tips.

Patent document WO00/49949 likewise describes a fixation systemcomprising a fastening element of biocompatible material consisting of adisk-shaped head and a shank, in which said shank has a surface havingratchet teeth thereon, said fastening element consisting of a second,also disk-shaped, closure element, provided with an opening throughwhich the shank can be inserted for the purpose of bringing the twodisk-shaped elements together until the upper and lower edges of thebone fragments to be joined together.

These types of devices such as those described in patent documentWO00/49949 are difficult to manufacture and store because of their sizeand because of the fact that they consist of an element from the centralpart of which there extends a shaft that is integral and perpendicularto the plane defined by the same, and they are subjected to a moredemanding load state since the load is concentrated in the joint betweenthe shaft and the disk-shaped head, whereby existing a higherprobability of failure, especially when it is made with non-metallicmaterials.

Furthermore, many of these devices comprising two plates or elementsjoined by a rigid shaft involve the drawback that their entire surfacedoes not adapt to different thicknesses and irregularities of thecranium and/or flap, resulting from the actual anatomy of this party ofthe body.

Most of these devices, specially designed to join bone flaps to thecranial bone mass, must be applied with the use of complex instruments,such as applicators suitable for engaging the shaft or shank joining thedisk-shaped elements; and provided with means of pushing one of saiddisks, which is moved over the mentioned shaft in order to be close toits homologue.

The object of this invention provides novel solutions to the problems ofmanufacture, storage, resistance, adaptation to bone thicknesses andplacement of bone fragment particularly bone flap, fixation devices. Itis furthermore easy to apply due to simple elements provided in theactual fixation device and allows the possibility of being adjustedwithout the need for additional instruments.

DISCLOSURE OF THE INVENTION

The fixation device for the fixation of bone fragments object of thepresent invention is essentially characterized in that, being made ofbiocompatible material, it comprises a flexible strip and fasteningmeans, the strip having a length allowing the formation of a fasteningloop tightly fastening the bone fragments to be joined together, thefastening means being provided with at least one opening provided withinterlocking means allowing the passage of a free end of the strip andpreventing its extraction in the direction opposite to its insertion.

According to another feature of the invention, the strip has a lengthsuch that it allows the formation of a fastening loop tightened aroundof the bone fragments to be fastened, and the fastening means arearranged at one of the ends of the strip, being provided with an openingfor the passage of the opposite end of the strip.

According to a variant of interest, for the object of maximally huggingthe bone fragments encircled by the strip, the opening for the passageof the fastening means is oriented such that the portion of stripretained by the interlocking means is arranged such that it isessentially tangential to the formed loop.

In a particular embodiment, the fastening means are arranged in aclosure plate, intended for being applied against the surface of thebone fragments and forming together with the strip one and the same bodywhich is susceptible of adopting an essentially planar position in aninoperative position.

According to another variant of the invention, particularly intended forthe fixation of a bone flap in the replacement thereof in acorresponding aperture made in the cranium or cranial bone mass, thedevice comprises two essentially planar plates connected by means of theflexible strip, one of which plates is a closure plate, intended forbeing applied against a face of the bone fragments, provided with thefastening means; and the other plate is a support plate, intended forbeing applied against another face of the mentioned bone fragments.

According to a preferred embodiment, the support plate is arrangedintegral and forming a single piece with the strip, or longitudinallymovable, between the two ends of the mentioned strip, forming anassembly which is susceptible of adopting an essentially planar positionin an inoperative position.

According to another feature of this variant of the invention, theclosure plate is a detachable plate, the fastening means being providedwith two openings for the passage of respective opposite ends of thestrip.

In one embodiment the device incorporates auxiliary gripping meansmaking it easier to handle the device and regulate the tightness of theclosure plate against the outer face of the bone fragments.

According to another variant of the invention, also intended for thefixation of a bone flap in an aperture made in the cranium, the closureplate is integral with one of the ends of the strip, forming a singlepiece with the strip, the fastening means being provided with an openingfor the passage of the opposite end of the strip.

With regard to the configuration of the strip, according to anotherfeature of the invention, such strip is provided with a rough surface onat least one of its faces, a series of projections being formed whichare suitable for collaborating with the interlocking means of theopening or openings, as the case may be, of the irreversible fasteningmeans.

BRIEF DESCRIPTION OF THE DRAWINGS

The attached drawings show by way of a non-limiting illustration severalembodiments for a fixation device for the fixation of bone fragmentsaccording to the invention. In said drawings:

FIGS. 1 and 2 are perspective views of respective variants of the deviceaccording to the invention in which the strip forms a long enough loopso as to encircle the bone fragments to be fastened.

FIGS. 3 to 7 are depictions of different variants, or views of one andthe same variant, of devices suitable for the fixation of a bone flap inan aperture made in the cranium or cranial bone mass, of which:

FIG. 3 is a perspective view of a third variant of the device in aninoperative position, in which it has an essentially planar shape;

FIG. 4 is a perspective view of a fourth variant of the device also inan inoperative position, in which it has an essentially planar shape;

FIG. 5 is a view of the device according to FIG. 4 during a surgicalintervention;

FIG. 6 a is a section view of the device according to FIG. 4 in itsoperative position;

FIG. 6 b is a view similar to that of FIG. 6 a of a device according toa fifth variant of the invention;

FIG. 7 is a view of the device according to FIG. 3 provided withauxiliary gripping means; and

FIG. 8, is a view of a sixth variant of the invention, in an operativeposition, illustrating its adaptability to a cranium with irregularthickness.

DETAILED DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 show first and second variants of the device 1 accordingto the invention for the joining of bone fragments, for example for thejoining of two fragments 2 a and 2 b of a tibia (see FIG. 2).

The device 1 of FIG. 1 comprises a flexible strip 4, having a lengthallowing the formation of a fastening loop tightened around the bonefragments to be fastened, and irreversible fastening means 5 arranged atone of the ends of the strip 4. Said fastening means 5 are provided withan opening 6 which is provided with interlocking means 7 allowing thepassage of the free end of the strip 4 and preventing its extraction inthe direction opposite to its insertion.

In the variant of FIG. 1, the opening 6 for the passage of the fasteningmeans 5 is oriented such that the portion of strip 4 c retained by theinterlocking means 7 is arranged such that it is essentially tangentialto the formed loop, whereby the strip can completely hug the bonefragments, especially when the fractured bone has a circular section.

In the variant of FIG. 2, the fastening means 5 are arranged in anessentially planar closure plate 8 intended for being applied againstthe surface of the bone fragments 2 a and 2 b.

FIGS. 3 and 4 depict third and fourth variants of particular embodimentssuitable for the fixation of a bone flap in an aperture made in thecranium or cranial bone mass. In both embodiments the device 1 comprisestwo plates connectable by means of the strip 4 flexible, one of whichplates is a support plate 9, intended for being applied against theinner face of the mentioned bone fragments, and the other one is aclosure plate 8, intended for being applied against the outer face ofthe mentioned bone fragments. The support plate 9 is a plate arrangedbetween the two ends of the mentioned strip 4, respective opposing stripsegments 4 a and 4 b being formed on both sides of the strip 4. Thesupport plate 9 is integrally formed together with the body of the strip4, forming a single body which adopts an essentially planar positionwhen it is not operative.

With regard to the closure plate 8, it is detachable and provided withfastening means 5, which are provided with two openings 6 a, 6 b for thepassage of respective opposite ends of the strip 4 for the formation ofa closed loop as will be explained in detail below.

FIG. 3 shows that the support plate 9 is provided in its entire contourwith multiple peripheral, flexible and elastic flanges 12, radiallydirected, in a somewhat inclined plane, from the plane of the supportplate 9 towards the bone fragments on which said support plate 9 isintended to be supported. Advantageously, each flange 12 is separatedfrom the adjacent flanges by respective cuts 13 made in the periphery ofthe support plate 9, such that the flanges 12 are wider at their outerend than at their joining to the support plate 9. The support plate 9 islikewise provided at its central portion with a plurality of ribs 14arranged parallel to the plane in which the two strip segments 4 a and 4b are inscribed.

It can also be seen in FIG. 3 that the strip segments 4 a and 4 b arejoined diametrically opposite to the support plate 9 at respective areasof smaller section 15 a, 15 b than that of the rest of the support plate9.

The areas of smaller section 15 a and 15 b along with the ribs 14 makeit easier for the support plate 9 to adapt to the inner face of thecranial bone mass, allowing it to slightly bend, when the strip segments4 a and 4 b exert pressure around the shaft marked by the direction ofthe ribs 14.

These features give the support plate 9 better gripping on the surfaceof the bone fragments and ensure that the strip 4, once the loop isformed and tightened, remains tensed due to the pulling effect that theflanges 12 transmit to the support plate 9 since the flanges want torecover their original position.

In the variant of FIG. 3, the closure plate 8 is provided with apartially weakened transverse area 16, suitable for giving the platesufficient flexibility for the best possible coupling to the irregularconfiguration of the bone surface on which it must be supported. It thusachieves that the closure plate 8 can slightly bend along an imaginaryline passing through the weakened areas of the closure plate 8, thusadapting to the outer face of the cranial bone mass, said shaft beingadvantageously perpendicular to the shaft which the support plate 9bends, whereby achieving better support of the device 1 to the cranialbone mass.

FIG. 5 depicts a device formed by the combination of a strip 4 accordingto the device according to FIG. 4 and a closure plate 8 according to thedevice of FIG. 4. In this FIG. 5 the free ends of the strip segments 4 aand 4 b have been inserted through the openings 6 a and 6 b,respectively, of the fastening means 5 provided for such purpose in theclosure plate 8, a closed loop connecting the support plate 9 and theclosure plate 8 having been formed.

During the application of the device 1, the support plate 9 is firstsupported against the inner face of the outer edges of the cranial bonemass 3 a and of the bone flap 3 b, and the closure plate 8 subsequentlyslides along the strip segments 4 a and 4 b towards the outer face ofthe cranial bone mass 3 a and the flap 3 b until being applied againstsaid outer face. Then the strip segments 4 a and 4 b are cut to thelevel of the closure plate 8, depicted in FIG. 6 a, the device 1 thusbeing placed in an operative position.

For the purpose of making it easier to slide the closure plate 8 towardsthe bone mass, the invention envisages incorporating auxiliary grippingmeans to thus simultaneously grip both strip segments 4 a and 4 b andkeep them tensed with one hand, such that with the other hand theclosure plate 8 can be slid along the two strip segments 4 a and 4 balso simultaneously.

In the variants of FIGS. 5 and 7, the mentioned gripping means 10 areformed by a handle 11 the ends of which are provided with respectiveopenings 11 a and 11 b provided with respective interlocking meansallowing the passage of corresponding free ends of the segments 4 a and4 b of the strip 4, preventing their extraction in the directionopposite to their insertion. These interlocking means can be formedsimilarly to the interlocking means, detailed below, provided in theopenings 6 a and 6 b of the fastening means 5 of the closure plate 8.

Once the device 1 is positioned in the aperture of the cranium, thegripping means 10 prevent the support plate 9 from being moved andhitting against soft tissue (brain) and damaging it when the surgeonbegins the movement of the closure plate 8 towards the support plate 9,without the need for additional instruments.

Alternatively, said gripping means 10 can consist of, with an equivalentfunction, respective extensions perpendicular to the free ends of thestrip segments 4 a and 4 b, like knobs. The gripping means 10 can alsoconsist of the joining of the ends of the strip segments 4 a and 4 b,for example by fusing the materials forming them, as shown in FIG. 8.

FIG. 8 depicts another variant of the device according to the inventionin which, unlike the devices of FIGS. 3 to 7, the closure plate 8 isintegral with one of the ends of the strip 4, forming a single piecewith it, and in which the fastening means 5 are provided with a singleopening 6 for the passage of the opposite end of the strip 4. In thisvariant, for the purpose of being able to regulate the separationdistance between the support plate 9 and the closure plate 8, adjustingit to the thickness of the cranial bone mass 3 a, the support plate 9 issuitable for being longitudinally movable along the strip 4. For suchpurpose, the support plate 9 is preferably provided with a throughopening longitudinally traversing the support plate 9, through which thestrip 4 passes. According to another embodiment, the support plate 9 canbe provided with a longitudinal groove in its outer face, having a widthsimilar to the width of the strip 4, inside of which the mentioned strip4 would be tightly housed when the loop is formed and the support plate9 is applied, under pressure, against the inner face of the bone mass.

This variant of the invention can also apply in the case of wanting tojoin cracked or broken bone fragments, such as bones with considerablycircular cross section (tibias, fibulas, ulnas, ribs, etc.). It can alsoapply in operations in which the sternum must be cut along thelongitudinal axis, for example, when it is necessary to access theorgans in the upper part of the chest, such as the heart or lungs.

The fastening means 5 of the device 1 are commonly arranged in theclosure plate 8 in all the variants of the device 1 depicted in FIGS. 2to 8. Even though in some variants the fastening means are provided withtwo openings for the passage of two free ends of the strip 4 and inother variants with a single opening, these openings have a contour thatis complementary or similar to the cross section of the strip 4 and areprovided with interlocking means 7 visible in the examples of FIGS. 6 a,6 b and 8.

The mentioned interlocking means 7 consist of an elastic tab, formedintegrally with the body of the closure plate 8, having a catch effect,cooperating with a ratchet tooth system provided at least at the apicalends or end of the strip 4. The ratchet tooth system comprises a roughsurface 17 on at least one of the faces of the strip 4, there beingformed a series of consecutive projections 18 suitable for collaboratingwith the interlocking means 7 of the opening or openings, as the casemay be, through which the strip 4 is passed. The elastic tabs preventand block the backward movement of the strip 4, ensuring the closure ofthe formed loop.

Preferably, the rough surface 17 is provided only on the inner face ofthe strip 4, because damage to adjacent structures is thus prevented.

The device 1 according to the invention is widely advantageous in itstransport and use because first in its inoperative position of storageor distribution, it takes up little space and can be completely planarwithout later compromising its functionality. This inoperative positionmakes it easier to transport and distribute the devices 1, which can bestored or distributed in small size and small volume packages, such asenvelopes or relatively thin cases.

In addition, the device 1 allows being applied to individuals withvariations regarding the thickness of the bone since long enough strips4 are envisaged for being adapted to different bone thicknesses.Furthermore, the same device 1 perfectly adapts, without the formationof projections, being uniformly tensed on its entire surface, to thedifferent thicknesses that may existing in one and the same bonefragment of an individual.

This is particularly relevant because the reality of individuals indeedshows that one and the same person may present thickness variations inone and the same bone, not just because of anatomy but also because ofparticularities of each individual. It is thus known that the craniumpresents areas of different thicknesses, but furthermore, these areasare also subject to variability between individuals. All this inter- andintra-individual variability is solved with the fixation device 1 objectof the invention, as shown in FIG. 8.

With a device 1 according to any one of the variants depicted in FIGS. 1to 8, operations can be performed in a wide range of people of differentages and sexes, or even in different animal species.

Furthermore, the devices 1 are easy to manufacture by common materialmolding or injection techniques.

Regarding the type of materials used for the manufacture of the fixationdevice 1 according to the invention, it is possible to use any materialof those known as biocompatible polymeric material, biocompatible metalallows, ceramics or composites of the foregoing. Generally,biocompatible, implantable and/or osteo-integratable materials arechosen, i.e., materials producing minimum reaction when introduced inthe animal or human body and which can furthermore make the neoformationor regeneration of bone tissue easier, the device be osteo-integratedand/or finally reabsorbed by the body after sufficient time has passedfor the groove, opening or cut to have been filled in with new tissue.These materials can furthermore be radiotransparent.

The invention claimed is:
 1. A method of fixating a cranial bone flapwith a cranial bone mass that involves the use of a fixation device thathas a support plate with an inner surface that is adapted to be appliedagainst the inner face of the outer edges of the cranial bone mass andthe cranial bone flap, the support plate having first and secondperipheral edges, a first flexible strip segment extending from thefirst peripheral edge and a second flexible strip segment extending fromthe second peripheral edge, the first and second flexible strip segmentsbeing integral and forming a single piece with the support plate, thefixation device having a closure plate with an outer surface and aninner surface, the inner surface adapted to be applied against the outerface of the outer edges of the cranial bone mass and the cranial boneflap, the closure plate having first and second openings extending therethrough, each of the first and second openings adapted to respectivelyreceive the first and second flexible strip segments, each of the firstand second openings having associated therewith an interlocking featurethat permits the passage and movement of the first and second flexiblestrip segments in a first direction through the respective first andsecond openings while preventing movement in a second direction oppositethe first direction, the first and second flexible strip segments extendthrough the respective first and second openings of the closure plate toform with the support plate a closed loop, the closure plate beingmoveable along the first and second flexible strips in a directiontoward the support plate, the fixation device having a handle with afirst end and a second end, a portion of the first and second flexiblestrip segments respectively coupled to the first and second ends, theclosure plate being positioned on the first and second flexible stripsegments between the handle and the support plate, the methodcomprising: placing the inner surface of the support plate against theinner face of the outer edges of the cranial bone mass and the cranialbone flap, with the use of a first hand applying tension to the firstand second flexible strip segments by gripping and pulling the handle inthe first direction to prevent the support plate from being moved andhitting against soft brain tissue without the need for additionalinstruments, with the use of a second hand sliding the closure platealong the first and second flexible strip segments toward the outer faceof the cranial bone mass and cranial bone flap until the inner surfaceof the closure plate is applied against the outer face; and severingeach of the first and second flexible strip segments at the outersurface of the closure plate.
 2. The method according to claim 1,wherein the support plate is at least partially conformable to the innerface of the outer edges of the cranial bone mass and the cranial boneflap and the closure plate is at least partially conformable to theouter face of the outer edges of the cranial bone mass and the cranialbone flap, the method comprising applying with the second hand duringthe step of sliding sufficient pressure to the closure plate to causethe closure plate to at least partially conform to the outer face of theouter edges of the cranial bone mass and the cranial bone flap.
 3. Themethod according to claim 2, wherein while using the second hand toslide the closure plate along the first and second flexible stripsegments toward the outer face of the cranial bone mass and cranial boneflap until the inner surface of the closure plate is applied against theouter face, also applying tension to the first and second flexible stripsegments by gripping and pulling the handle in the first direction bythe first hand to cause the support plate to at least partially conformto the inner face of the outer edges of the cranial bone mass and thecranial bone flap.
 4. A method of fixating a cranial bone flap with acranial bone mass that involves the use of a fixation device that has asubstantially planar support plate with an inner surface that is adaptedto be applied against the inner face of the outer edges of the cranialbone mass and the cranial bone flap, the support plate having first andsecond geometrically opposed peripheral edges, a first flexible stripsegment extending from the first peripheral edge and a second flexiblestrip segment extending from the second peripheral edge, the first andsecond flexible strip segments being integral and forming a single piecewith the support plate, the fixation device having a substantiallyplanar closure plate with an outer surface and an inner surface, theinner surface adapted to be applied against the outer face of the outeredges of the cranial bone mass and the cranial bone flap, the closureplate having first and second openings extending there through, each ofthe first and second openings adapted to respectively receive the firstand second flexible strip segments, each of the first and secondopenings having associated therewith an interlocking feature thatpermits the passage and movement of the first and second flexible stripsegments in a first direction through the respective first and secondopenings while preventing movement in a second direction opposite thefirst direction, the first and second flexible strip segments extendthrough the respective first and second openings of the closure plate toform with the support plate a closed loop, the closure plate beingmoveable along the first and second flexible strips in a directiontoward the support plate, the fixation device having a handle with afirst end and a second end, a portion of the first and second flexiblestrip segments respectively secured to the first and second ends, theclosure plate being positioned on the first and second flexible stripsegments between the handle and the support plate, the methodcomprising: placing the inner surface of the support plate against theinner face of the outer edges of the cranial bone mass and the cranialbone flap, with the use of a first hand applying tension to the firstand second flexible strip segments by gripping and pulling the handle inthe first direction to prevent the support plate from being moved andhitting against soft brain tissue without the need for additionalinstruments, with the use of a second hand sliding the closure platealong the first and second flexible strip segments toward the outer faceof the cranial bone mass and cranial bone flap until the inner surfaceof the closure plate is applied against the outer face; and severingeach of the first and second flexible strip segments at the outersurface of the closure plate.
 5. The method according to claim 4,wherein the support plate is at least partially conformable to the innerface of the outer edges of the cranial bone mass and the cranial boneflap and the closure plate is at least partially conformable to theouter face of the outer edges of the cranial bone mass and the cranialbone flap, the method comprising applying with the second hand duringthe step of sliding sufficient pressure to the closure plate to causethe closure plate to at least partially conform to the outer face of theouter edges of the cranial bone mass and the cranial bone flap.
 6. Themethod according to claim 5, wherein while using the second hand toslide the closure plate along the first and second flexible stripsegments toward the outer face of the cranial bone mass and cranial boneflap until the inner surface of the closure plate is applied against theouter face also applying tension to the first and second flexible stripsegments by gripping and pulling the handle in the first direction bythe first hand to cause the support plate to at least partially conformto the inner face of the outer edges of the cranial bone mass and thecranial bone flap.
 7. A method of fixating a cranial bone flap with acranial bone mass that involves the use of a fixation device that has asupport plate with an inner surface that is adapted to be appliedagainst the inner face of the outer edges of the cranial bone mass andthe cranial bone flap, the support plate at least partially conformableto the inner face of the outer edges of the cranial bone mass and thecranial bone flap and having first and second peripheral edges, a firstflexible strip segment extending from the first peripheral edge and asecond flexible strip segment extending from the second peripheral edge,the first and second flexible strip segments being integral and forminga single piece with the support plate, the fixation device having aflexible closure plate with an outer surface and an inner surface, theinner surface adapted to be applied against the outer face of the outeredges of the cranial bone mass and the cranial bone flap, the closureplate at least partially conformable to the outer face of the outeredges of the cranial bone mass and the cranial bone flap and havingfirst and second openings extending there through, each of the first andsecond openings adapted to respectively receive the first and secondflexible strip segments, each of the first and second openings havingassociated therewith an interlocking feature that permits the passageand movement of the first and second flexible strip segments in a firstdirection through the respective first and second openings whilepreventing movement in a second direction opposite the first direction,the first and second flexible strip segments extend through therespective first and second openings of the closure plate to form withthe support plate a closed loop, the closure plate being moveable alongthe first and second flexible strips in a direction toward the supportplate, the fixation device having a handle with a first end and a secondend, a portion of the first and second flexible strip segmentsrespectively secured to the first and second ends, the closure platebeing positioned on the first and second flexible strip segments betweenthe handle and the support plate, the method comprising: placing theinner surface of the support plate against the inner face of the outeredges of the cranial bone mass and the cranial bone flap, with the useof a first hand applying tension to the first and second flexible stripsegments by gripping and pulling the handle in the first direction toprevent the support plate from being moved and hitting against softbrain tissue without the need for additional instruments, with the useof a second hand sliding the closure plate along the first and secondflexible strip segments toward the outer face of the cranial bone massand cranial bone flap until the inner surface of the closure plate isapplied against the outer face, applying with the second hand sufficientpressure to the closure plate to cause the closure plate to at leastpartially conform to the outer face of the outer edges of the cranialbone mass and the cranial bone flap while applying tension to the firstand second flexible strip segments by gripping and pulling the handle inthe first direction by the first hand to cause the support plate to atleast partially conform to the inner face of the outer edges of thecranial bone mass and the cranial bone flap; and severing each of thefirst and second flexible strip segments along the outer surface of theclosure plate.